Quality and Certifications
We are proud of our quality track record: GLP/GMP-certified, GCP compliant, inspected by EMA, FDA, relevant health authorities and periodic client audits. Our three EU sites are systematically monitored by Corporate Quality Assurance to uphold a unified quality system across the group. All analytical work and processes are regulated by Standard Operating Procedures (SOP) in compliance with Good Laboratory Practices (GLP), Good Clinical Practices (GCP) or Good Manufacturing Practices (GMP). A LIMS system is implemented for instruments integration, data integrity and traceability. We are Certified EU Importers of medicinal products with Quality Control managers for batch testing and Qualified Persons (QPs) for batch release certification.
Our latest FDA inspections were successfully completed on May 2020 (Kymos; FEI #3008661256) and April 2019 (Pharmaprogress; FEI #3002860914).
Pharmaprogress Certifications
Du to pandemic reasons the AIFA has decided to extend the validity of all GMP certificates to 31/12/2023
AFI Symposium
Rimini, IT | 07-09 Jun 2023 | Booth #94
farmaforum
Madrid, E |20-21 September 2023 | Booth K15
CPHI 2023
Barcelona, ES | 24-26 Oct 2023 | Booth 2R60
TIDES EU
Amsterdam, NL | 16-18 Nov 2022 |